BINDER SUBMALAR (R) IMPLANT
Received Oct 6, 2017 · Event occurred Jun 21, 2017
Report 2028924-2017-00006 · MDR key 6923692
Device
Generic name
Malar Implant
Manufacturer
Implantech Associates, Inc.Model number
N/ACatalog number
BSM-M
Lot number
869223
Product problems
- Contamination
Patient
34 YR
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
EVALUATION SUMMARY: METHOD: THE ACTUAL DEVICE WAS NOT EVALUATED, HOWEVER IMPLANTECH REVIEWED STERILIZATION RECORDS, MANUFACTURING RECORDS, AND PRODUCT LABELING. RESULTS: NO FAILURE WAS DETECTED. CONCLUSION: THE POSSIBILITY OF INFECTION IS A KNOWN, INHERENT RISK ASSOCIATED WITH IMPLANT SURGERY.
Description of Event or Problem
COMPLAINANT REPORTED THAT PATIENT COMPLAINED OF LEFT CHEEK TENDERNESS AND HAD LEFT SIDE CHEEK IMPLANT EXPLANTED DUE TO INFECTION APPROXIMATELY 3 MONTHS POST-OPERATIVELY. NO CULTURE WAS TAKEN, SO NO ORGANISM HAS BEEN IDENTIFIED. AS OF (B)(6) 2017, PHYSICIAN FELT INFECTION APPEARS TO BE RESOLVED. NOTE: THE COMPLAINANT REPORTED THAT RHINOPLASTY, NECK LIFT, LIP LIFT, MANDIBLE AND FOREHEAD CONTOURING WITH BROW LIFT AND SCALP ADVANCEMENT WERE CITED AS CONCOMITANT MEDICAL THERAPIES.